Advertisement
+91 8617752708

International Journal of TROPICAL DISEASE & Health, ISSN: 2278-1005,Vol.: 29, Issue.: 1

Short Research Article

Efinaconazole 10% Topical Solution: Treatment of Mild to Moderate Toenail Onychomycosis in Japanese Subjects

 

Theodore Rosen1* and Tina Lin2

1Department of Dermatology at Baylor College of Medicine, Houston, Texas, USA.

2Valeant Pharmaceuticals North America LLC., Bridgewater, New Jersey, USA.

Article Information

Editor(s):

(1) Jorge Paredes Vieyra, Universidad Autonoma De Baja California, Campus Tijuana, Mexico.

Reviewers:

(1) Shari Lipner, Weill Cornell Medicine, USA.

(2) K. R. Raghavendra, Mysore Medical College and Research Institute, India.

Complete Peer review History: http://www.sciencedomain.org/review-history/23157

Abstracts

Objective: To evaluate efficacy, safety, and tolerability of efinaconazole topical solution, 10% in a cohort of Japanese patients with mild to moderate toenail onychomycosis.

Methods: A subgroup analysis of patients, aged 22-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from a multicenter, double-blind, vehicle-controlled 48-week study evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52.

Results: The primary end point, complete cure, was achieved in 30.6% of patients treated with efinaconazole compared to 12.3% with vehicle (Observed case, P=.006), and was significantly better than that seen in the non-Japanese patients (P<.001). Treatment success (percent affected target toenail ≤10% at week 52) for efinaconazole was 60.6% compared to 33.3% with vehicle (P<.001). The majority of adverse events (AEs) were mild (16.6%) or moderate (81.1%) and few (7.8%) associated with efinaconazole. Eleven patients (6.0%) treated with efinaconazole discontinued the study due to AEs.

Conclusions: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of mild to moderate onychomycosis among ethnic Japanese patients.

Keywords :

Efinaconazole; onychomycosis; japanese subjects.

Full Article - PDF    Page 1-7 Article Metrics

DOI : 10.9734/IJTDH/2018/36283

Review History    Comments

Our Contacts

Guest House Road, Street no - 1/6,
Hooghly, West Bengal,
India

+91 8617752708

 

Third Floor, 207 Regent Street
London, W1B 3HH,
UK

+44 20-3031-1429